Assistant Manager-Regulatory Affairs

About the role

The Assistant Manager – Regulatory Affairs will be responsible for managing site-level regulatory activities and documentation for the API manufacturing facility and will work closely with the Central Regulatory Affairs team to ensure regulatory readiness, compliance and timely support for customer and health authority requirements.

What you'll do

• Own and coordinate day-to-day regulatory activities at the API manufacturing site
• Ensure site practices, processes and documentation remain aligned with applicable regulatory requirements and registered commitments
• Act as the primary regulatory interface between the manufacturing site and the Central Regulatory Affairs team
• Maintain regulatory readiness of the site for customer, partner and health authority requirements
• Regulatory Documentation & Submissions

What you need

• 8–10 yrs of experience
• Regulatory affairs
• GMP
• Documentation
• Quality control
• M.Sc or B.Pharm or M.Pharm